Parkinson's disease (PD) is a common disorder that affects the brain's ability to control movement. More than one million people in North America have been diagnosed with PD, most of whom are over 60 years old. Parkinson's progressively worsens over time, although the rate of worsening varies greatly from person to person. Many people with the disease who are treated may be able to live years without serious disability. A number of treatments are available to help manage the symptoms and improve a person's quality of life. However, there is no cure for the disease at this time.
Essential tremor is a disorder of the nervous system that causes a rhythmic shaking or tremor. It can affect almost any part of the body but the trembling most often occurs in the hands and is especially bothersome during the attempt to do simple tasks like drinking from a glass or writing with a pencil. Essential tremor may also affect one's head, voice, arms, or legs. While it is not the same as Parkinson's disease, the tremor of Parkinson's disease resembles essential tremor and some of the same treatments, e.g., deep brain stimulation, are given to both disorders.
The cause of Parkinson's disease is unknown. (Note, throughout this application, “Parkinson's disease” may be shortened to just “Parkinson's”.) Normally, certain nerve cells called neurons in the brain make a chemical called dopamine that helps control movement. In people with Parkinson's, these neurons slowly degenerate and lose their ability to produce dopamine. As a result, the symptoms of Parkinson's develop gradually and tend to become more severe over time. It is not well understood how and why these neurons stop working correctly.
The signs and symptoms of Parkinson's can be divided into motor and nonmotor. Motor symptoms are those that affect movement of the body. These are the most obvious symptoms of the disease. The main motor symptoms of Parkinson's are tremor, slowness of movement (called “bradykinesia”), stiffness (“rigidity”), and poor balance (“postural instability” or “gait impairment”). These symptoms are usually mild in the early stages of the disease.
Symptoms typically start on one side of the body and spread to the other side over a few years. As symptoms worsen, a patient may have difficulty walking, talking, and performing daily tasks. While the symptoms typically progress slowly, progression varies from person to person. During the early stages of the disease, symptoms can be managed fairly well with drugs.
The symptom of tremor caused by Parkinson's disease is the most noticeable when a person is at rest. The tremor of early Parkinson's is intermittent and may not be noticeable to others. Tremor usually becomes noticeable one hand at a time, spreading to the second hand over a period of a few years.
The symptom of bradykinesia or slowness of movement eventually affects everyone with the disease. It may result in feelings of lack of coordination, weakness, and fatigue. In the arms, bradykinesia can cause difficulty with daily tasks like buttoning clothing and clicking a computer mouse. It may cause a patient to drag his legs when walking, take shorter shuffling steps, or have a feeling of unsteadiness. A person may also have difficulty standing from a chair or getting out of a car.
The symptom of rigidity causes stiffened movement of the arms, legs, or body. It usually begins on the same side of the body as the other early symptoms and similarly to other symptoms, eventually affects the other side.
The symptom of postural instability deals with the failure of automatic reflexes that help a person remain balanced when standing and walking. The loss of balance or falling usually does not occur until late in the progression of the disease. However, postural instability may require a patient to use assistance of another person or a wheelchair to get around. Postural instability early in the disease state is suggestive of another Parkinsonism syndrome and not Parkinson's disease.
The nonmotor symptoms of the disease are those unrelated to movement. Many nonmotor symptoms affect a person's mood, the five senses, and the ability to think. Problems with thinking and problems with memory commonly occur in the disease and can range from mild to severe. Some studies indicate that forty percent or more of patients are affected with these problems over the long term. Common cognitive symptoms include difficulty making decisions or multi-tasking, remembering events, and judging distances.
Psychosis, or the disorder of thinking that causes a person to lose touch with reality, occurs in twenty to forty percent of people treated with medication for Parkinson's disease. The underlying cause of psychosis is poorly understood, although many medications used to treat Parkinson's can cause psychosis as a side effect, particularly in a person who already has cognitive impairment. Visual hallucinations are the most common symptoms of psychosis in Parkinson's and they often become more frequent and severe as the disease progresses.
In addition to psychosis, mood disorders such as depression, anxiety, and loss of motivation are common in people with Parkinson's. All of these conditions decrease a person's quality of life and worsen motor symptoms.
People with Parkinson's disease also have sleep disorders and excessive daytime sleepiness affects about 75 percent of people with the disease. It may be worsened by the medications used to treat Parkinson's. Some simply feel sleepy while others experience sudden and unintentional sleeping periods during the daytime.
There can be some autonomic dysfunction in Parkinson's with symptoms such as low blood pressure after standing up, constipation, difficulty swallowing, abnormal sweating, urinary leakage, and libido dysfunction.
One's sense of smell is commonly lost by people with Parkinson's. It usually happens early in the course of the disease even before many of the more familiar symptoms appear and it often goes unnoticed by the patient.
Painful sensations are also reported by Parkinson's patients—by more than 40 percent of patients. The pain can be piercing or stabbing, burning or tingling, and may be felt in several places or only in specific areas of the body including the face, abdomen, genitals, and joints. In general, painful sensations are experienced in the same body parts as the motor symptoms, and may be more prominent as medications wear off.
The diagnosis of Parkinson's disease relies upon the patient's signs and symptoms and not a blood or imaging test. Generally, bradykinesia (or slow movement) must be present to make a diagnosis and one of the two other primary symptoms: tremor and rigidity. Other factors supportive of the diagnosis are: symptoms began on one side of the body; the tremor occurs as the person's limb is resting; and the symptoms can be controlled with Parkinson's medication.
An alternative approach for treating Parkinson's disease, and/or Essential Tremor and a host of other physiological conditions, illnesses, deficiencies and disorders is acupuncture, which includes traditional acupuncture and acupressure. Acupuncture has been practiced in Eastern civilizations (principally in China, but also in other Asian countries) for at least 2500 years. It is still practiced today throughout many parts of the world, including the United States and Europe. A good summary of the history of acupuncture, and its potential applications may be found in Cheung, et al., “The Mechanism of Acupuncture Therapy and Clinical Case Studies”, (Taylor & Francis, publisher) (2001) ISBN 0-415-27254-8, hereafter referred to as “Cheung, Mechanism of Acupuncture, 2001.” The Forward, as well as Chapters 1-3, 5, 7, 8, 12 and 13 of Cheung, Mechanism of Acupuncture, 2001, are incorporated herein by reference.
Despite the practice in Eastern countries for over 2500 years, it was not until President Richard Nixon visited China (in 1972) that acupuncture began to be accepted in the West, such as the United States and Europe. One of the reporters who accompanied Nixon during his visit to China, James Reston, from the New York Times, received acupuncture in China for post-operative pain after undergoing an emergency appendectomy under standard anesthesia. Reston experienced pain relief from the acupuncture and wrote about it in The New York Times. In 1973 the American Internal Revenue Service allowed acupuncture to be deducted as a medical expense. Following Nixon's visit to China, and as immigrants began flowing from China to Western countries, the demand for acupuncture increased steadily. Today, acupuncture therapy is viewed by many as a viable alternative form of medical treatment, alongside Western therapies. Moreover, acupuncture treatment is now covered, at least in part, by most insurance carriers. Further, payment for acupuncture services consumes a not insignificant portion of healthcare expenditures in the U.S. and Europe. See, generally, Cheung, Mechanism of Acupuncture, 2001, vii.
Acupuncture is an alternative medicine that treats patients by insertion and manipulation of needles in the body at selected points. See, Novak, Patricia D. et al (1995). Dorland's Pocket Medical Dictionary (25th ed.), Philadelphia: (W.B. Saunders Publisher), ISBN 0-7216-5738-9. The locations where the acupuncture needles are inserted are referred to herein as “acupuncture points” or simply just “acupoints”. The location of acupoints in the human body has been developed over thousands of years of acupuncture practice, and maps showing the location of acupoints in the human body are readily available in acupuncture books or online. For example, see, “Acupuncture Points Map,” found online at: http://www.acupuncturehealing.org/acupuncture-points-map.html. Acupoints are typically identified by various letter/number combinations, e.g., L6, S37. The maps that show the location of the acupoints may also identify what condition, illness or deficiency the particular acupoint affects when manipulation of needles inserted at the acupoint is undertaken.
References to the acupoints in the literature are not always consistent with respect to the format of the letter/number combination. Some acupoints are identified by a name only, e.g., Tongli. The same acupoint may be identified by others by the name followed with a letter/number combination placed in parenthesis, e.g., Tongli (HT5). Alternatively, the acupoint may be identified by its letter/number combination followed by its name, e.g., HT5 (Tongli). The first letter(s) typically refers to a body organ or meridian, or other tissue location associated with, or affected by, that acupoint. However, usually only the letter(s), not the name of the body organ or tissue location, is used in referring to the acupoint, but not always. Thus, for example, the acupoint GV20 is the same as acupoint Governing Vessel 20 which is the same as GV-20 which is the same as GV 20 which is the same as Baihui. For purposes of this patent application, unless specifically stated otherwise, all references to acupoints that use the same name, or the same first letter and the same number, and regardless of slight differences in second letters and formatting, are intended to refer to the same acupoint.
An excellent reference book that identifies all of the traditional acupoints within the human body is WHO STANDARD ACUPUNCTURE POINT LOCATIONS IN THE WESTERN PACIFIC REGION, published by the World Health Organization (WHO), Western Pacific Region, 2008 (updated and reprinted 2009), ISBN 978 92 9061 248 7 (hereafter “WHO Standard Acupuncture Point Locations 2008”). The Table of Contents, Forward (page v-vi) and General Guidelines for Acupuncture Point Locations (pages 1-21), as well as pages 188 and 213 (which illustrate with particularity the location of acupoints GB34 and GV20, respectively) of the WHO Standard Acupuncture Point Locations 2008 are incorporated herein by reference.
While many in the scientific and medical community are highly critical of the historical roots upon which acupuncture has developed, (e.g., claiming that the existence of meridians, qi, yin and yang, and the like have no scientific basis), see, e.g., http://en.wikipedia.org/wiki/Acupuncture, few can refute the vast amount of successful clinical and other data, accumulated over centuries of acupuncture practice, that shows needle manipulation applied at certain acupoints is quite effective.
The World Health Organization and the United States' National Institutes of Health (NIH) have stated that acupuncture can be effective in the treatment of neurological conditions and pain. Reports from the USA's National Center for Complementary and Alternative Medicine (NCCAM), the American Medical Association (AMA) and various USA government reports have studied and commented on the efficacy of acupuncture. There is general agreement that acupuncture is safe when administered by well-trained practitioners using sterile needles, but not on its efficacy as a medical procedure.
An early critic of acupuncture, Felix Mann, who was the author of the first comprehensive English language acupuncture textbook, Acupuncture: The Ancient Chinese Art of Healing, stated that “The traditional acupuncture points are no more real than the black spots a drunkard sees in front of his eyes.” Mann compared the meridians to the meridians of longitude used in geography—an imaginary human construct. See, Mann, Felix (2000). Reinventing acupuncture: a new concept of ancient medicine. Oxford: Butterworth-Heinemann. pp. 14; 31. ISBN 0-7506-4857-0. Mann attempted to combine his medical knowledge with that of Chinese theory. In spite of his protestations about the theory, however, he apparently believed there must be something to it, because he was fascinated by it and trained many people in the West with the parts of it he borrowed. He also wrote many books on this subject. His legacy is that there is now a college in London and a system of needling that is known as “Medical Acupuncture”. Today this college trains doctors and Western medical professionals only.
For purposes of this patent application, the arguments for and against acupuncture are interesting, but not that relevant. What is important is that a body of literature exists that identifies several acupoints within the human body that, rightly or wrongly, have been identified as having an influence on, or are otherwise somehow related to, the treatment of Parkinson's disease and Essential Tremor. With respect to these acupoints, the facts speak for themselves. Either these points do or do not affect the conditions, deficiencies or illnesses with which they have been linked. The problem lies in trying to ascertain what is fact from what is fiction. This problem is made more difficult when conducting research on this topic because the insertion of needles, and the manipulation of the needles once inserted, is more of an art than a science, and results from such research become highly subjective. What is needed is a much more regimented approach for doing acupuncture research.
It should also be noted that other medical research, not associated with acupuncture research, has over the years identified nerves and other locations throughout a patient's body where the application of electrical stimulation produces a beneficial effect for the patient. Indeed, the entire field of neurostimulation deals with identifying locations in the body where electrical stimulation can be applied in order to provide a therapeutic effect for a patient. For purposes of this patent application, such known locations within the body are treated essentially the same as acupoints—they provide a “target” location where electrical stimulation may be applied to achieve a beneficial result, whether that beneficial result is to reduce cholesterol or triglyceride levels, to reduce excess body fat, to treat cardiovascular disease, to treat mental illness, or to address some other issue associated with a disease or condition of the patient.
Returning to the discussion regarding acupuncture, some have proposed applying moderate electrical stimulation at selected acupuncture points through needles that have been inserted at those points. See, e.g., http://en.wikipedia.org/wiki/Electroacupuncture. Such electrical stimulation is known as electroacupuncture (EA). According to Acupuncture Today, a trade journal for acupuncturists: “Electroacupuncture is quite similar to traditional acupuncture in that the same points are stimulated during treatment. As with traditional acupuncture, needles are inserted on specific points along the body. The needles are then attached using small clips to an external device that generates continuous electric pulses. These devices are used to adjust the frequency and intensity of the impulse being delivered, depending on the condition being treated. Electroacupuncture uses two needles at a time so that the impulses can pass from one needle to the other. Several pairs of needles can be stimulated simultaneously, usually for no more than 30 minutes at a time.” “Acupuncture Today: Electroacupuncture”. 2004 Feb. 1 (retrieved on-line 2006 Aug. 9 at http://www.acupuncturetoday.com/abc/electroacupuncture.php).
U.S. Pat. No. 7,155,279, issued to Whitehurst et al., discloses use of an implantable miniature neurostimulator, referred to as a “microstimulator,” that can be implanted for stimulation of the vagus nerve and used as a therapy (alongside drugs) for movement disorders.
Other patents of Whitehurst et al. teach the use of this small, microstimulator, placed in other body tissue locations, including within an opening extending through the skull into the brain, for the treatment of a wide variety of conditions, disorders and diseases. See, e.g., U.S. Pat. No. 6,735,475 (headache and facial pain); U.S. Pat. No. 7,003,352 (epilepsy by brain stimulation); U.S. Pat. No. 7,013,177 (pain by brain stimulation); U.S. Pat. No. 6,950,707 (obesity and eating disorders); U.S. Pat. No. 7,292,890 (Vagus nerve stimulation); U.S. Pat. No. 7,203,548 (cavernous nerve stimulation); U.S. Pat. No. 7,440,806 (diabetes by brain stimulation); U.S. Pat. No. 7,610,100 (osteoarthritis); and U.S. Pat. No. 7,657,316 (headache by stimulating motor cortex of brain).
Techniques for using electrical devices, including external EA devices, for stimulating peripheral nerves and other body locations for treatment of various maladies are known in the art. See, e.g., U.S. Pat. Nos. 4,535,784; 4,566,064; 5,195,517; 5,250,068; 5,251,637; 5,891,181; 6,393,324; 6,006,134; 7,171,266; 7,171,266 and 7,373,204. The methods and devices disclosed in these patents, however, typically utilize (i) large implantable stimulators having long leads that must be tunneled through tissue over an extended distance to reach the desired stimulation site, (ii) external devices that must interface with implanted electrodes via percutaneous leads or wires passing through the skin, or (iii) inefficient and power-consuming wireless transmission schemes. Such devices and methods are still far too invasive, or are ineffective, and thus subject to the same limitations and concerns as are the previously described electrical stimulation devices.
From the above, it is seen that there is a need in the art for a less invasive device and technique for electroacupuncture stimulation of acupoints that does not require the continual use of needles inserted through the skin, or long insulated wires implanted or inserted into blood vessels, for the purposes of improving the symptoms of or slowing the progression of Parkinson's disease and Essential Tremor.